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Parker Hannifin Corporation 245 Township Line Road Hatfield, PA 19440 USA Office 215-723-4000 ® Nitronox Plus Instructions for Use and Installation Guide FM-1406 Rev. D www.porterinstrument.com/nitronox 15JAN2025...
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Representation Parker Hannifin Corporation Precision Fluidics Division Legal Manufacturer 245 Township Line Road Hatfield, PA 19440 USA Office: (215) 723-4000 EMERGO Europe European Westervoortsedijk 60 Communities 6827 AT Arnhem, The Netherlands Authorized Representative Tel: +31 70 345 8570 Compliance with conformity assessment on quality Conformité...
The Nitronox Plus is intended to provide a mixture of N , on demand, to a conscious, spontaneously breathing patient. The Nitronox Plus is designed for use with adult and pediatric patients and is not intended to be used with infants or neonates.
The Nitronox Plus is not used for the administration of general anesthesia or as part of, or in conjunction with, a general anesthesia administration system. The user should observe the patient to prevent over sedation in the event of an oxygen failsafe malfunction or crossed lines.
Safety Features Oxygen Piloted Regulator (Failsafe) The Nitronox Plus utilizes an oxygen piloted regulator that only supplies nitrous oxide when oxygen supply pressure is present. If the oxygen supply gas is depleted or disconnected, the device will discontinue mixed gas delivery until oxygen supply pressure is restored.
It is the responsibility of the medical establishment and the medical professional to develop specific delivery protocols for administration of nitrous oxide using the Nitronox Plus. Specific delivery protocols for adult and pediatric patients should be developed; the Nitronox Plus is not intended to be used with infants or neonates.
Specifications Dimensions Weight 10.8 in L x 9.8 in W x 7.3 in H 13 lbs. (5.9 kg) (26.9 cm L x 25.1 cm W x 18.5 cm H) Connection Fittings Mixture Settings Oxygen Inlet: DISS 1240 (Male) Adjustable 0-70% N2O (0-70% model) Nitrous Oxide Inlet: DISS 1040A (Male) Adjustable 0-50% N2O (0-50% model) Mixed Gas Connection Port: 22 mm taper...
2 Cylinder Mobile Cart Thread the mounting pin (1) into the mounting hole on the bottom of the Nitronox Plus (2) until it is tight, then tighten the locking nut to secure the pin. Lift the Nitronox Plus and drop the mounting pin (1) into the mounting hole (2) on the top of the 2 Cylinder Mobile Cart.
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Wall Arm Mount Thread the mounting pin (1) into the mounting hole on the bottom of the Nitronox Plus (2) until it is tight, then tighten the locking nut (3) to secure the pin. Lift the Nitronox Plus and drop the mounting pin into the...
Do not discharge the gas at any person or flammable material. Ensure the device is securely mounted to an accessory (as described in Section 0) and the gas supply hoses are connected to the correct fittings on the Nitronox Plus (as described in Section 2.3).
(45-60psi), or the mixture pressure is out of the green band (30-40 psi). Breathing Circuit and Mask Installation Note: The Nitronox Plus is compatible with the Medical Breathing Circuit (DMC-part series). Connect the Tee fitting of the Medical Breathing Circuit (1) to the Connection Port (2) on the front of the Nitronox Plus.
WARNING: Never use a mask strap to hold the mask to a patient’s face. Self-administration is a safety feature of the Nitronox Plus; if for any reason the patient were to become over sedated, the patient will be unable to adequately hold the mask in a tight sealing position against the face. The lack of a tight seal results in the demand valve being unable to trigger, and therefore the supply of mixed gas will cease, allowing the patient to breathe room air through the mouth or nose.
4. Maintenance The Nitronox Plus has an expected service lifetime of 10 years. The device requires proper maintenance, pre-checks, and servicing. Once the device reaches an age of 10 years, a failed pre- check will indicate that the device has reached the end of its useful life.
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Alarm Function Test To test the device alarms, ensure the N O Key Lock is in the ON position. For adjustable models, set the O knob to 50% (no setting required for 50/50 model). Ensure the gas supply lines are installed correctly. Open the supply valves to pressurize the system and confirm the O and N O inlet pressure gauges are within the green band.
Cleaning the Device The Nitronox Plus must be cleaned between each use in order to prevent the spread of infections. Cleaning of the device has been validated with Super Sani-Cloth™ Germicidal wipes. WARNING: Do not wipe the inside of the inlet fittings, gas supply hoses, or connection port as this may deposit cleaning agents into the breathing pathway of the device.
Servicing the Demand Valve The demand valve utilized in the Nitronox Plus requires periodic service (every 5 years). For information on servicing the demand valve, contact your authorized distributor. Removing the Demand Valve Loosen rear panel screw using a 5/32” hex key (1) then remove the rear panel (2).
5. Symbols Glossary The following symbols are used throughout this document, as well as on device labels and packaging. Symbol Title of Symbol Description of Symbol Indicates the medical device manufacturer and is accompanied by the name and address of the Manufacturer manufacturer.
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Symbol Title of Symbol Description of Symbol Indicates important cautionary or warning information to the user that is presented in the instructions for use Caution/Warning that accompanies explanatory instructions to the user. [EN ISO 15223-1:2021, clause 5.4.4] Indicates that the product should not be used near any magnetic resonance equipment.
Parker Hannifin Corporation. Parker Hannifin Corporation shall not be liable for any damage, injury or loss arising out of the use of the product, whether as a result of a defect in the product or otherwise, if, prior to such damage, injury or loss, the product was (1) damaged or misused;...
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